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Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake (NUDGE-FLU)

Primary Purpose

Influenza, Behavior and Behavior Mechanisms

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Behavioral Economic Principles

About this trial

This is an interventional other trial for Influenza focused on measuring Influenza, Vaccination, Nudging, Behavioral Science

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age >=65 years at January 15, 2023 (eligible for free influenza vaccination in the official Danish vaccination program)
Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

1) Persons living in nursing homes

Sites / Locations

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

No Intervention

Experimental

Arm Label

Control

Standard Letter

Priming & Hot State Activation - 1 reminder

Depersonalized Letter

Gain-Framing/Context

Loss-Framing/Context

Collective Goal

Active Choice/Implementation Intention Prompt

Cardiovascular Gain Frame

Expert Authority

Arm Description

No letter

This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement

The standard letter sent out two times instead of once

The standard letter without the recipient's name

Text added to the standard letter employing the specified behavioral economic principle

Outcomes

Primary Outcome Measures

Number of participants who received an influenza vaccine

Secondary Outcome Measures

Time from intervention delivery to influenza vaccination

Full Information

NCT ID

NCT05542004

First Posted

August 31, 2021

Last Updated

June 5, 2023

Sponsor

Tor Biering-Sørensen

Collaborators

Statens Serum Institut, Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT05542004

Brief Title

Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

Acronym

NUDGE-FLU

Official Title

Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 16, 2022 (Actual)

Primary Completion Date

January 1, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tor Biering-Sørensen

Collaborators

Statens Serum Institut, Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. This study will investigate investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among eligible influenza vaccination candidates.

Detailed Description

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons identified as eligible for free-of-charge influenza vaccination in the Danish health system aged 18 years and above. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10) and the Anatomical Therapeutic Chemical (ATC) classification system. Individuals will be randomized to 1 of 10 arms (1 control arm and 9 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms. The study will be performed in collaboration with the Danish Health Data Authority and Statens Serum Institut.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Behavior and Behavior Mechanisms

Keywords

Influenza, Vaccination, Nudging, Behavioral Science

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

964870 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

No letter

Arm Title

Standard Letter

Arm Type

Experimental

Arm Description

This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement

Arm Title

Priming & Hot State Activation - 1 reminder

Arm Type

Experimental

Arm Description

The standard letter sent out two times instead of once

Arm Title

Depersonalized Letter

Arm Type

Experimental

Arm Description

The standard letter without the recipient's name

Arm Title

Gain-Framing/Context

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Arm Title

Loss-Framing/Context

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Arm Title

Collective Goal

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Arm Title

Active Choice/Implementation Intention Prompt

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Arm Title

Cardiovascular Gain Frame

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Arm Title

Expert Authority

Arm Type

Experimental

Arm Description

Text added to the standard letter employing the specified behavioral economic principle

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Economic Principles

Intervention Description

The control arm will receive no letter to reflect the background vaccination uptake. Intervention arms will test the effects of different letters developed using behavioral economic principles.

Primary Outcome Measure Information:

Title

Number of participants who received an influenza vaccine

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Time from intervention delivery to influenza vaccination

Time Frame

Up to 3 months

Other Pre-specified Outcome Measures:

Title

Number of participants with laboratory-confirmed influenza

Time Frame

Up to 8 months

Title

Number of participants with a hospitalization with influenza or pneumonia

Time Frame

Up to 8 months

Title

Number of participants with any hospitalization

Time Frame

Up to 8 months

Title

All-cause mortality

Time Frame

Up to 8 months

Title

Composite of incident heart failure, heart failure hospitalization, or cardiovascular death

Time Frame

Up to 8 months

Title

Composite of myocardial infarction, stroke, or cardiovascular death

Time Frame

Up to 8 months

Title

Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death

Time Frame

Up to 8 months

Title

Number of participants with incident heart failure or heart failure hospitalization

Time Frame

Up to 8 months

Title

Cardiovascular death

Time Frame

Up to 8 months

Title

Number of participants with myocardial infarction

Time Frame

Up to 8 months

Title

Number of participants with coronary revascularization

Time Frame

Up to 8 months

Title

Number of participants with stroke

Time Frame

Up to 8 months

Title

Number of contacts to general practitioner (excluding vaccination visit)

Time Frame

Up to 8 months

Title

Number of participants with laboratory-confirmed COVID-19

Time Frame

Up to 8 months

Title

Number of participants with a hospitalization due to COVID-19

Time Frame

Up to 8 months

Title

Number of participants who received a COVID-19 vaccine

Time Frame

Up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >=65 years at January 15, 2023 (eligible for free influenza vaccination in the official Danish vaccination program) Access to the official, mandatory Danish electronic mailbox system Exclusion Criteria: 1) Persons living in nursing homes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tor Biering-Sørensen, MD, PhD, MPH

Organizational Affiliation

Research Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

City

Hellerup

State/Province

Hovedstaden

ZIP/Postal Code

2900

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Learn more about this trial

Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

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